A Randomized, Double-blind, Placebo-controlled Phase 3 Study: Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 Infection Rate and COVID-19 Severity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- COVID-19 infection
研究概览
简要总结
Bacille Calmette-Guerin (BCG) is a live attenuated vaccine administered for prevention of tuberculosis. Recently, several groups have hypothesized that BCG may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for COVID-19. Trials are currently being conducted in Australia, Netherlands, Germany and the United Kingdom to evaluate its effectiveness.
Front line workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. They are at high risk of infection from COVID-19, with potentially high infection rate. The investigators propose an interventional trial to evaluate the effectiveness of BCG vaccination to prevent COVID-19 infection and reduce its severity in front-line employees in Ontario.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
The clinical trial is designed as a double-blind (observer blind) study. Observer-blind means that during the course of trial, the companions/parents/guardians of the subjects and the study personnel responsible for the evaluation of any study endpoint will be unaware which vaccine was administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eighteen years of age or older
- •Employee/member of: municipal or provincial police service, emergency medical services, fire services, public transport service, health service, food manufacturing facility
排除标准
- •Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood.
- •Previous known history of latent or active tuberculosis
- •Known kidney, liver or blood disorders which impairs organ and marrow function
- •Chronic administration of steroids (>10 mg prednisone) at the time of randomization
- •Current or planned concomitant biologic therapy in the next 7 months.
- •Known hypersensitivity or allergy to components of VPM1002
- •Pregnant or planning to become pregnant in the future 7 months.
- •Breastfeeding.
- •Current suspected viral or bacterial infection.
- •Body temperature > 38° C
- •Participation in another interventional study with potentially conflicting medication within 30 days before screening.
- •The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-TNF therapy, methotrexate, azathioprine, antimalarials).
- •Active malignancy requiring treatment.
- •Known positive HIV serology.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.
- •Previous positive COVID-19 confirmed infection.
- •Uncontrolled intercurrent illness.
- •Psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Placebo
A single dose of 0.1 mL of the 0.9% sodium chloride injection, administered via intradermal injection.
干预措施: Placebo (Other)
VPM1002
A single dose of 0.1 mL of the reconstituted vaccine containing VPM1002 (Mycobacterium bovis rBCGΔureC::hly, live 2-8 × 105 CFU), administered via intradermal injection.
干预措施: VPM1002 (Biological)
结局指标
主要结局
COVID-19 infection
时间窗: 7 months
To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.
次要结局
- Incidence of ARDS(7 months)
- Secondary infection in COVID-19(7 months)
- Incidence of hospitalization for COVID-19(7 months)
- Incidence of DVT(7 months)
- COVID-19-related Mortality(7 months)
- Incidence of ICU admission for COVID-19(7 months)
- Mechanical ventilation for COVID-19(7 months)